Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

3

Prescription Drugs

Human prescription drugs including biological products

Medical Devices

Medical devices intended for human use; Approved or cleared medical devices

Biological Products

Requires analytical comparability per ICH Q5E

Stakeholders

9

Manufacturer

Entity responsible for submitting NDINs

Distributor

Entity responsible for submitting NDINs

Health Care Professional

Intended users such as nurses in a nonemergency setting

Consumer

layman using the drug safely

Medical Science Liaison

Agent acting on behalf of the firm.

Key Opinion Leader

Paid speaker acting on behalf of the firm.

Medical Personnel

Responses should be generated by medical or scientific personnel

Sales Personnel

Sales and marketing personnel should have no input on the content of responses

Marketing Personnel

Sales and marketing personnel should have no input on the content of responses

Regulatory Context

Regulatory Activities

2

510(k)

Premarket notification submission type

Premarket Notification

A medical device submission type (510(k)).

Document Types

8

Labeling

Cybersecurity information should be included in device labeling

Promotional Labeling

FDA considers HCEI communications to payors to be promotional labeling.

Advertising

Marketing materials evaluated in TPPI studies

Standard Response

Prepared responses generated from pull-down menus on a website

Scientific Reprints

Response should include complete copies of scientific reprints

FDA-required labeling

Labeling reviewed and approved by FDA as part of premarket review; Firms should include a copy of the most current labeling in SIUU communications; Official labeling containing approved use information

FDA-approved package insert

Example of FDA-required labeling

Boxed Warning

Specific labeling requirement for safety

Attributes

1

Unsolicited Request

A request for information that is not prompted by the firm

Technical Details

Clinical Concepts

2

Diabetes

Therapeutic area standard

Arthritis

Objective manifestation of Lyme disease used in endpoint assessment.; Treatment failure manifestation in natural history studies

Identified Hazards

Hazards

1

Fetal Harm

Example of risk information that should be disclosed

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

Failure to maintain complete and accurate treatment records

4

Adulteration of an Animal Offered for Human Consumption

3

Failure to maintain treatment records

2

Failure to implement procedures for reviewing treatment records

1

Extralabel use of EXCEDE without veterinary supervision

1

Extralabel use of enrofloxacin

1

Adulterated food due to illegal drug residues

1

Extralabel use of ceftiofur hydrochloride

1

Extralabel use of a drug not in conformance with its approved labeling

1

Extralabel use of a prohibited drug

1